AND IMPORTANCE TO TRANSLATIONAL AND CLINICAL RESEARCH I Translational research is complex, interdisciplinary, and the discipline is fast-changing. It requires ahextensive toolkit of skills that must be maintained as the field quickly evolves. Translational research education and career development are the foundation of the Institute of Translational Health Sciences (ITHS). Indeed, every Core of the ITHS has a strong dynamic educational component. The Research Education, Training, and Career Development Core will facilitate the development and evolution of research skills in every phase of a translational investigator's career. LA. Overall alms I.A.1. Integrate oredoctoral. postdoctoral, early career, and continuing research education with the resources of the ITHS cores to create a continuum of translational research training. This continuum will address research training needs at all levels from student to senior investigator, with multiple entry points. We will integrate previously distinct threads in three Roadmap programs (T32, K30, and K12), other translational and clinical research training in the partner institutions, and continuing education for investigators and researchstaff. I.A.2. Train a new cadre of translational investigators who have depth in a specific area of research, broad knowledge about the full spectrum of translational investigation, and skills in research team building. We will provide them with a toolkit of methodologic knowledge and practical skills for the design and ethical conduct of rigorous translational and clinical research. We aim to provide outstanding mentors, infuse trainees with the excitement of translational research, and nurture early career development. I.B. Specific Alms I.B.1. Integrate predoctoral. postdoctoral, early career, and continuing research education needs I.B.I.a. Create curriculum for the full range of translational research training. The goal is to facilitate optimal training for ITHS T32 and K12 participants, but also for other trainees .(K awardees, T32-supported fellows, residents, professional students, and graduate students). This includes "Continuing Translational Research Education" for investigators and research staff at all levels of experience, with short courses, informal courses and certificate programs, in addition to formal degree programs. We continue a tuition support program for trainees and junior faculty to obtain a Master's Degree in Clinical Research outside the more formal T32 and K12 programs (I.B.2). I.B.1.b. Serve as an integrator for other translational research training programs, resources of all 6 Health Science schools, and the ITHS partners. This effort will include expanding the environment for peer interaction currently in the Roadmap T32, K30, and K12 programs to the entire ITHS, in particular K awardees. This occurs through seminars, work-in-progress sessions, research proposal review opportunities, and informal gatherings. Such interactions have didactic value, but also enhance interpersonal skills, collaborative and multidisciplinary thinking, and the ability to provide and receive constructive feedback. I.B. I.e. Develop newtraining and recognition for excellent research mentors and team collaboration. I.B.2. Train a new cadre of translational investigators. This aim is built around two formal training programs that may culminate in a Master's Degree in a new Clinical Research Track. The degree will cover the major theories and methods of disciplines relevant to translational research. This allows trainees to integrate their thinking through the spectrum of research, from pre-clinical experiments to initial human studies to routine care. Training programs will foster the transition from mentored research to original independent projects appropriate to the level of trainee. Research projects will provide the methodologic experience, practical tools, and content knowledge necessary to launch a research career. Establishing an effective multidisciplinary mentorship team for each trainee is an essential component of this aim. I.B.2.a. Continue the pre-doctoral (T32) training program already established at the UW. We will continue to recruit outstanding applicants to predoctoral (T32) program from a diverse applicant pool, emphasizing not only race/ethnic, disability and gender diversity, but also diversity of professions and specialties. The T32 program aims to enroll 12 trainees/year in a Master's degree training program and 12 additional trainees per year in a summer intensive research experience. PHS 398/2590 (Rev. 09/04, Reissued4/2006) : 'Page Continuation Format Page 690 Principal Investigator/Program Director (Last, First, Middle): DisJS, Mary L. I.B.2.b. Continue the postdoctoral/early faculty (K12)training and career development program already established at the UW. We will continue to recruit outstanding applicants to the early faculty (K12) program from a diverse applicant pool, emphasizing not only race/ethnic, disability and gender diversity, but also diversity of professions and specialties. The K12 program aims for a steady state of approximately 21 junior faculty Scholars distributed through a 5-year career-development program. QPTBEI00RE: II.A. We have already established a basic curriculum based on translational research emphasis areas. In 2003, the Institute of Medicine's Clinical Research Roundtable identified two impediments to applying science expeditiously to improve human health [1, 2]. The first involves translation of new laboratory understanding into diagnostic, treatment, and prevention strategies ready for initial testing in humans. We have labeled this the "discovery" phase of translation. The second occurs when clinical research results are translated into everyday clinical practice, which we have labeled the "implementation" phase. Between these obstacles lies the challenge of evaluating new tests and treatments in controlled clinical trials (Fig. 1). The Research Education, training, and Career Development Core will focus on the first 4 translational obstacles listed at the top of Figure 1: the lack of qualified investigators, fragmented infrastructure, career disincentives, and lack of funding. The broader ITHS addresses many of the remaining issues. Basic Biomedical & Translation from basic science Translation of-new knowledge . Biobehavioral to human studies into clinical practice and Research & community health etiologic epidemiology T T Emphasis Area: Discovery Emphasis Area; .Emphasis Area: Implementation - Translational Research Clinical Trials Outcomes, Clinical Epidemiology, and Health Services Research Figure 1; Translational obstacles in the clinical research continuum and the emphasis areas of the ITHS integrated training program. Modified from [3] The University of Washington (UW) has been at the forefront of NIH Roadmap initiatives to develop interdisciplinary research teams of the future and to reengineer clinical research training. Over the past five years, with NIH support, we have developed innovative predoctoral, postdoctoral and early career programs in multidisciplinary clinical and translational research: K30 (5K30RR022293-07, J. Brunzell, Director), K12 (5K12RR023265-03, R. Deyo, Program Director) and T32 (5 T32 RR023256-02, P. Mitchell & S. Marshall, Program Directors). These programs serve as building blocks for an integrated Research Education, Training, and Career Development Core. We will expand on these programs to develop training that may be accessed by any junior investigator and develop core curricula designed for more seasoned investigators. Via our existing Roadmap programs, we have made excellent progress in increasing the number of qualified investigators, finding many outstanding applicants, creating research career incentives, forming community partnerships through trainees' projects, and informally linking portions of the training infrastructure. The creation of the ITHS will allow us to more globally transcend the narrow specialty orientation and relative isolation of many scientific training programs and help future researchers understand the full spectrum of translational research. To address this full spectrum and attract a broad range of trainees and investigators into our programs, our approach will have 3 overlapping translational emphasis areas: [unreadable] Discovery Translational Research, focused on late stage pre-clinical research and initial translation from bench to patient-centered human studies. This is most analogous to Phase I studies in FDA terminology. PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page Continuation Format Page 691